EXHIBIT 99.1
FACTORS POSSIBLY AFFECTING FUTURE OPERATING RESULTS
From time to time, Wilson Greatbatch Technologies, Inc. (the Company) publishes
forward-looking statements relating to anticipated financial performance,
business development (including mergers, acquisitions, and other commercial
arrangements), product development and regulatory approval timelines,
intellectual property matters, market developments and similar matters. A
variety of factors could cause the company's actual results and experience to
differ materially from those projected, including the following:
Risks Related To Our Business
We depend heavily on a limited number of customers, and if we lose any of them
or they reduce their business with us, we would lose a substantial portion of
our revenues.
A substantial portion of our business is conducted with a limited
number of customers, including Guidant, St. Jude Medical, Medtronic, Sorin /
ELA, Biotronik and Halliburton. In 2004, Guidant, St. Jude Medical, and
Medtronic collectively accounted for approximately 70% of our revenues. Our
supply agreements might not be renewed. Furthermore, our supply agreements do
not all contain minimum purchase level requirements and therefore there is no
guaranteed source of revenue that we can depend upon under these agreements. The
loss of any large customer or a reduction of business with that customer for any
reason would harm our business, financial condition and results of operations.
If we do not respond to changes in technology, our products may become obsolete
and we may experience a loss of customers and lower revenues.
We sell our products to customers in several industries that are
characterized by rapid technological changes, frequent new product introductions
and evolving industry standards. Without the timely introduction of new products
and enhancements, our products and services will likely become technologically
obsolete over time and we may lose a significant number of our customers. In
addition, other new products introduced by our customers may require fewer of
our batteries or components. We dedicate a significant amount of resources to
the development of our products and technologies and we would be harmed if we
did not meet customer requirements and expectations. Our inability, for
technological or other reasons, to successfully develop and introduce new and
innovative products could result in a loss of customers and lower revenues.
If we are unable to successfully market our current or future products, our
business will be harmed and our revenues and operating results will be reduced.
The market for our medical products has been growing in recent years.
If the market for our products does not grow as rapidly as forecasted by
industry experts, our revenues could be less than expected. In addition, it is
difficult to predict the rate at which the market for our products will grow or
at which new and increased competition will result in market saturation. Slower
growth in the pacemaker, ICD and CRT markets in particular would negatively
impact our revenues. In addition, we face the risk that our products will lose
widespread market acceptance. We cannot assure you that our customers will
continue to utilize the products we offer or that a market will develop for our
future products. We may at times determine that it is not technically or
economically feasible for us to continue to manufacture certain products and we
may not be successful in developing or marketing them. Additionally, new
technologies that we develop may not be rapidly accepted because of
industry-specific factors, including the need for regulatory clearance,
entrenched patterns of clinical practice and uncertainty over third party
reimbursement. If this occurs, our business will be harmed and our revenues and
operating results will be negatively affected.
1
We are subject to pricing pressures from customers, which could harm our
operating results.
We have made price concessions to some of our large customers in recent
years and we expect customer pressure for pricing concessions will continue.
Further, price concessions or reductions may cause our operating results to
suffer. In addition, any delay or failure by a large customer to make payments
due to us also could harm our operating results or financial condition.
We rely on third party suppliers for raw materials, key products and
subcomponents and if we are unable to obtain these materials, products and
subcomponents on a timely basis or on terms acceptable to us, our ability to
manufacture products will suffer.
Our business depends on a continuous supply of raw materials. The
principal raw materials used in our business include lithium, iodine, tantalum,
platinum, ruthenium, gallium trichloride, tantalum pellets, vanadium pentoxide,
iridium, and titanium. Raw materials needed for our business are susceptible to
fluctuations due to transportation, government regulations, price controls,
economic climate or other unforeseen circumstances. Increasing global demand for
some of the raw materials we need for our business, including platinum, iridium,
gallium trichloride, tantalum and titanium, has caused the prices of these
materials to increase significantly. In addition, there are a limited number of
worldwide suppliers of several raw materials needed to manufacture our products,
including lithium gallium trichloride, carbon monofluoride, and tantalum. We
cannot assure you that we will be able to continue to procure raw materials
critical to our business or to procure them at acceptable price levels.
We rely on third party manufacturers to supply many of our raw
materials. Manufacturing problems may occur with these and other outside
sources, as a supplier may fail to develop and supply products and subcomponents
to us on a timely basis, or may supply us with products and subcomponents that
do not meet our quality, quantity and cost requirements. If any of these
problems occur, we may be unable to obtain substitute sources of these products
and subcomponents on a timely basis or on terms acceptable to us, which could
harm our ability to manufacture our own products and components profitably or on
time. In addition, to the extent the processes that our suppliers use to
manufacture products and subcomponents are proprietary, we may be unable to
obtain comparable subcomponents from alternative suppliers.
2
We may never realize the full value of our intangible assets, which represent a
significant portion of our total assets.
At December 31, 2004, we had $220.8 million of intangible assets,
representing 46% of our total assets. These intangible assets consist primarily
of goodwill, trademarks, tradenames and patented technology arising from our
acquisitions. Goodwill and other intangible assets with indefinite lives are no
longer amortized, they are tested annually or upon the occurrence of certain
events to determine if impairment is indicated. We may not receive the recorded
value for our intangible assets if we sell or liquidate our business or assets.
In addition, the material concentration of intangible assets increases the risk
of a large charge to earnings in the event that the recoverability of these
intangible assets is impaired, and in the event of such a charge to earnings,
the market price of our common stock could be adversely affected. In addition,
intangible assets with definite lives, which represent $64.0 million of our net
intangible assets at December 31, 2004, will continue to be amortized. We
incurred total amortization expenses relating to these intangible assets of $4.0
million in 2004. These expenses will reduce our future earnings or increase our
future losses.
Quality problems with our products could harm our reputation for producing high
quality products, erode our competitive advantage and result in claims against
us.
Our products are held to high quality standards. In the event that our
products fail to meet these standards, our reputation for producing high quality
products could be harmed, which would damage our competitive advantage and could
result in lower revenues. From time to time quality or performance issues have
arisen regarding our products. Product quality or performance issues, however,
may arise in the future that could have a significant adverse impact on us,
either because they harm our reputation for high quality, result in a product
liability or other legal claim against us, harm our reputation with our
customers or result in a decline in our stock price.
If we become subject to product liability claims, our operating results and
financial condition could suffer.
The manufacture and sale of our products expose us to potential product
liability claims and product recalls, including those that may arise from
failure to meet product specifications, misuse or malfunction of, or design
flaws in, our products, or use of our products with components or systems not
manufactured or sold by us. Many of our products are components and function in
interaction with our customers' medical devices. For example, our batteries are
produced to meet various electrical performance, longevity and other
specifications, but the actual performance of those products is dependent on how
they are in fact utilized as part of the customers' devices over the lifetime of
the products. Product performance and device interaction from time to time have
been, and may in the future be, different than expected for a number of reasons.
Consequently, it is possible that customers may experience problems with their
medical devices that could require device recall or other corrective action,
where our batteries met the specification at delivery, and for reasons that are
not related primarily or at all to any failure by our product to perform in
accordance with specifications. It is possible that customers (or patients) may
in the future assert that our products caused or contributed to device failure
where our product was not the primary cause of the device performance issue.
Even if such assertions do not lead to product liability or contract claims,
they could harm our reputation and our customer relationships.
3
Provisions contained in our agreements with key customers attempting to
limit our damages, including provisions to limit damages to liability for gross
negligence, may not be enforceable in all instances or may otherwise fail to
protect us from liability for damages. Product liability claims or product
recalls, regardless of their ultimate outcome, could require us to spend
significant time and money in litigation or require us to pay significant
damages. The occurrence of product liability claims or product recalls could
cause our operating results and financial condition to suffer.
We carry product liability insurance coverage that is limited in scope
and amount. Our management believes that our insurance coverage is adequate
given the risks we face. We cannot assure you that we will be able to maintain
this insurance or to do so at a reasonable cost and on reasonable terms. We also
cannot assure you that this insurance will be adequate to protect us against a
product liability claim that arises in the future.
Our operating results may fluctuate, which may make it difficult to forecast our
future performance and may result in volatility in our stock price.
Our operating results have fluctuated in the past and are likely to
fluctuate significantly from quarter to quarter due to a variety of factors,
including:
o the fixed nature of a substantial percentage of our costs, which
results in our operations being particularly sensitive to fluctuations
in revenue;
o changes in the relative portion of our revenue represented by our
various products and customers, which could result in reductions in
our profits if the relative portion of our revenue represented by
lower margin products increases;
o timing of orders placed by our principal customers who account for a
significant portion of our revenues; and
o increased costs of raw materials or supplies.
4
If we are unable to protect our intellectual property and proprietary rights,
our business could be adversely affected.
We rely on a combination of patents, licenses, trade secrets and
know-how to establish and protect our proprietary rights to our technologies and
products. As of December 31, 2004, we held 246 active U.S. patents. We cannot
guarantee that the steps we have taken or will take to protect our proprietary
rights will be adequate to deter misappropriation of our intellectual property.
In addition to seeking formal patent protection whenever possible, we attempt to
protect our proprietary rights and trade secrets by entering into
confidentiality and non-compete agreements with employees, consultants and third
parties with which we do business. However, these agreements can be breached
and, if they are, there may not be an adequate remedy available to us and we may
be unable to prevent the unauthorized disclosure or use of our technical
knowledge, practices or procedures. If our trade secrets become known, we may
lose our competitive advantages.
In addition, we may not be able to detect unauthorized use of our
intellectual property and take appropriate steps to enforce our rights. If third
parties infringe or misappropriate our patents or other proprietary rights, our
business could be seriously harmed. We may be required to spend significant
resources to monitor our intellectual property rights, we may not be able to
detect infringement of these rights and may lose our competitive advantages
associated with our intellectual property rights before we do so. In addition,
competitors may design around our technology or develop competing technologies
that do not infringe on our proprietary rights.
5
We may be subject to intellectual property claims, which could be costly and
time consuming and could divert our management and key personnel from our
business operations.
In producing our batteries and other components for implantable medical
devices, third parties may claim that we are infringing their intellectual
property rights, and we may be found to have infringed those intellectual
property rights. While we do not believe that any of our products infringe the
intellectual property rights of third parties, we may be unaware of intellectual
property rights of others that may be used in our technology and products. In
addition, third parties may claim that our patents have been improperly granted
and may seek to invalidate our existing or future patents. Although we do not
believe that any of our active patents should be subject to invalidation, if any
claim for invalidation prevailed, the result could be greatly expanded
opportunities for third parties to manufacture and sell products that compete
with our products and our revenues from any related license agreements would
decrease accordingly. We also typically do not receive significant
indemnification from parties which license technology to us against third party
claims of intellectual property infringement. Any litigation or other challenges
regarding our patents or other intellectual property could be costly and time
consuming and could divert our management and key personnel from our business
operations. The complexity of the technology involved in producing our power
sources and other components for implantable medical devices, and the
uncertainty of intellectual property litigation increase these risks. Claims of
intellectual property infringement might also require us to enter into costly
royalty or license agreements. However, we may not be able to obtain royalty or
license agreements on terms acceptable to us, or at all. We also may be subject
to significant damages or injunctions against development and sale of our
products. Infringement claims, even if not substantiated, could result in
significant legal and other costs and may be a distraction to management.
We are dependent upon our senior management team and key personnel and the loss
of any of them could significantly harm us.
Our future performance depends to a significant degree upon the
continued contributions of our senior management team and key technical
personnel. Our products are highly technical in nature. In general, only highly
qualified and trained scientists have the necessary skills to develop our
products. The loss or unavailability to us of any member of our senior
management team or a key technical employee could significantly harm us. We face
intense competition for these professionals from our competitors, our customers
and other companies operating in our industry. To the extent that the services
of members of our senior management team and key technical personnel would be
unavailable to us for any reason, we would be required to hire other personnel
to manage and operate our company and to develop our products and technology. We
cannot assure you that we would be able to locate or employ such qualified
personnel on acceptable terms.
We may not be able to attract, train and retain a sufficient number of qualified
professionals to maintain and grow our business.
6
Our success will depend in large part upon our ability to attract,
train, retain and motivate highly skilled employees and management. There is
currently aggressive competition for employees who have experience in technology
and engineering. We compete intensely with other companies to recruit and hire
from this limited pool. The industries in which we compete for employees are
characterized by high levels of employee attrition. Although we believe we offer
competitive salaries and benefits, we may have to increase spending in order to
retain personnel.
We may make acquisitions that could subject us to a number of operational risks
and we may not be successful in integrating companies we acquire into our
existing operations.
We have made and expect to make in the future selective acquisitions
that complement our core competencies in technology and manufacturing to enable
us to manufacture and sell additional products to our existing customers and to
expand our business into related markets. However, implementation of our
acquisition strategy entails a number of risks, including:
o inaccurate assessments of undisclosed liabilities;
o diversion of our management's attention from our core businesses;
o potential loss of key employees or customers of the acquired
businesses;
o difficulties in integrating the operations and products of an acquired
business or in realizing projected efficiencies and cost savings; and
o increases in our indebtedness and a limitation in our ability to
access additional capital when needed.
If we are not successful in making acquisitions to expand and develop our
business, our operating results may suffer.
A component of our strategy is to make selective acquisitions that
complement our core competencies in technology and manufacturing to enable us to
manufacture and sell additional products to our existing customers and to expand
our business into related markets. Our continued growth will depend on our
ability to identify and acquire companies that complement or enhance our
business on acceptable terms. We may not be able to identify or complete future
acquisitions. Some of the risks that we may encounter include expenses
associated with and difficulties in identifying potential targets, the costs
associated with incomplete acquisitions, and higher prices for acquired
companies because of competition for attractive acquisition targets. Our failure
to acquire additional companies could cause our operating results to suffer.
7
We may face competition from our principal medical customers that could harm our
business and we may be unable to compete successfully against new entrants and
established companies with greater resources.
Competition in connection with the manufacturing of products may
intensify in the future. One or more of our customers may undertake additional
vertical integration initiatives and begin to manufacture some or all of their
components.
The market for commercial power sources is competitive, fragmented and
subject to rapid technological change. Many other commercial power source
suppliers are larger and have greater financial, operational, personnel, sales,
technical and marketing resources than our company. These and other companies
may develop products that are superior to ours, which could cause our results of
operations to suffer.
Accidents at one of our facilities could delay production and adversely affect
our operations.
Our business involves complex manufacturing processes and hazardous
materials that can be dangerous to our employees. Although we employ safety
procedures in the design and operation of our facilities, there is a risk that
an accident or death could occur in one of our facilities. Any accident, such as
a chemical spill, could result in significant manufacturing delays or claims for
damages resulting from injuries, which would harm our operations and financial
condition. The potential liability resulting from any such accident or death, to
the extent not covered by insurance, could cause our business to suffer. Any
disruption of operations at any of our facilities could harm our business.
We intend to expand into new markets and our proposed expansion plans may not be
successful, which could harm our operating results.
We intend to expand into new markets through the development of new
product applications based on our existing component technologies. These efforts
have required, and will continue to require us to make substantial investments,
including significant research, development and engineering expenditures and
capital expenditures for new, expanded or improved manufacturing facilities. We
may not be able to successfully manage expansion into new markets and products
and these efforts may harm our operating results. Specific risks in connection
with expanding into new markets include the inability to transfer our quality
standards into new products, the failure of customers in new markets to accept
our products and price competition.
8
Our failure to obtain licenses from third parties for new technologies or the
loss of these licenses could impair our ability to design and manufacture new
products and harm our revenues.
We occasionally license technologies from third parties rather than
depending exclusively on our own proprietary technology and developments. For
example, we license a capacitor patent from the Evans Capacitor Company. Our
ability to license new technologies from third parties is and will continue to
be critical to our ability to offer new and improved products. We may not be
able to continue to identify new technologies developed by others and even if we
are able to identify new technologies, we may not be able to negotiate licenses
on favorable terms, or at all. Additionally, we could lose rights granted under
licenses for reasons beyond our control. For example, the licensor could lose
patent protection for a number of reasons, including invalidity of the licensed
patent.
Our failure to timely or properly implement our new information systems could
adversely affect our business.
We are in the process of implementation of new information systems. Any
failures, difficulties or significant delays in implementing these new
information systems could result in material adverse consequences to our
business, including disruption of operations, loss of information and
unanticipated increases in costs.
Risks Related To Our Industries
We and our customers are subject to various political, economic and regulatory
changes in the healthcare industry which could force us to modify how we develop
and price our products.
The healthcare industry is highly regulated and is influenced by
changing political, economic and regulatory factors. Several of our product
lines are subject to international, federal, state and local health and safety,
packaging and product content regulations. In addition, implantable medical
devices produced by our medical customers are subject to regulation by the U.S.
Food and Drug Administration and similar governmental agencies. These
regulations govern a wide variety of product activities from design and
development to labeling, manufacturing, promotion, sales and distribution.
Compliance with these regulations may be time consuming, burdensome and
expensive and could negatively affect our customers' abilities to sell their
products, which in turn would adversely affect our ability to sell our products.
This may result in higher than anticipated costs or lower than anticipated
revenues.
These regulations are also complex, change frequently and have tended
to become more stringent over time. Federal and state legislatures have
periodically considered programs to reform or amend the U.S. healthcare system
at both the federal and state levels. In addition, these regulations may contain
proposals to increase governmental involvement in healthcare, lower
reimbursement rates or otherwise change the environment in which healthcare
industry participants operate. We may be required to incur significant expenses
to comply with these regulations or remedy past violations of these regulations.
Any failure by our company to comply with applicable government regulations
could also result in cessation of portions or all of our operations, impositions
of fines and restrictions on our ability to carry on or expand our operations.
In addition, because many of our products are sold into regulated industries, we
must comply with additional regulations in marketing our products.
9
Our business is subject to environmental regulations that could be costly for
our company to comply with.
Federal, state and local regulations impose various environmental
controls on the manufacturing, transportation, storage, use and disposal of
batteries and hazardous chemicals and other materials used in, and hazardous
waste produced by, the manufacturing of power sources and components. Conditions
relating to our historical operations may require expenditures for clean-up in
the future and changes in environmental laws and regulations may impose costly
compliance requirements on us or otherwise subject us to future liabilities.
Additional or modified regulations relating to the manufacture, transportation,
storage, use and disposal of materials used to manufacture our batteries and
components or restricting disposal of batteries may be imposed. In addition, we
cannot predict the effect that additional or modified regulations may have on us
or our customers.
Consolidation in the healthcare industry could result in greater competition and
reduce our medical component revenues and harm our business.
Many healthcare industry companies are consolidating to create new
companies with greater market power. As the healthcare industry consolidates,
competition to provide products and services to industry participants will
become more intense. These industry participants may try to use their market
power to negotiate price concessions or reductions for our products. If we are
forced to reduce our prices because of consolidation in the healthcare industry,
our revenues would decrease and our operating results would suffer.
Our medical business is indirectly subject to healthcare industry cost
containment measures that could result in reduced sales of our products.
Our healthcare customers rely on third party payors, such as government
programs and private health insurance plans, to reimburse some or all of the
cost of the procedures in which our products are used. The continuing efforts of
government, insurance companies and other payors of healthcare costs to contain
or reduce those costs could lead to patients being unable to obtain approval for
payment from these third party payors. If that occurred, sales of implantable
medical devices may decline significantly, and our customers may reduce or
eliminate purchases of our products. The cost containment measures that
healthcare providers are instituting, both in the United States and
internationally, could harm our ability to operate profitably.
Our non-medical power source revenues are dependent on conditions in the oil and
natural gas industry, which historically have been volatile.
10
Sales of our commercial products depend to a great extent upon the
condition of the oil and gas industry and, specifically, the exploration and
production expenditures of oil and gas companies. In the past, oil and natural
gas prices have been volatile and the oil and gas exploration and production
industry has been cyclical, and it is likely that oil and natural gas prices
will continue to fluctuate in the future. The current and anticipated prices of
oil and natural gas influence the oil and gas exploration and production
business and are affected by a variety of political and economic factors beyond
our control, including worldwide demand for oil and natural gas, worldwide and
domestic supplies of oil and natural gas, the ability of the Organization of
Petroleum Exporting Countries, or OPEC, to set and maintain production levels
and pricing, the level of production of non-OPEC countries, the price and
availability of alternative fuels, political stability in oil producing regions
and the policies of the various governments regarding exploration and
development of their oil and natural gas reserves. An adverse change in the oil
and gas exploration and production industry or a reduction in the exploration
and production expenditures of oil and gas companies could cause our revenues
from commercial products to suffer.
11